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The current problem with acupuncture research.

As an acupuncturist, one of the most common questions that I get asked is “Does acupuncture really work?” And, drawing on my own clinical experience and the thousands of years of other acupuncturists’ clinical experiences before me, I can confidently answer “yes, yes it does work.” However, in today’s modern scientific world, many people (including most doctors), want to see the evidence. This is a completely understandable desire and a very worthwhile inquiry into the art of acupuncture. However, the problem comes from how we define evidence. While I believe that there is an abundance of evidence that acupuncture works - from clinical experience, from ancient texts, from observational studies, and even from some well-designed controlled trials of acupuncture - the dominant medical system understands the effectiveness of a medical intervention almost solely through its effects in randomized controlled clinical trials.

Randomized controlled clinical trials were designed to test pharmaceutical drugs and control for patient expectations during the trial. Hence, the model evolved that one group of patients would be randomly assigned to receive the active drug, and one group would be randomly assigned to receive a placebo sugar pill, and no patients would know which treatment they were receiving.

For the past many decades, researchers have tried to figure out how to test acupuncture in a clinical trial in the same manner.

Like regulating the dose and method of administration in a pharmaceutical trial, they regulated each aspect of the acupuncture treatment – which points the acupuncturist would needle (which would be the same for each patient), how deep the needle would be, how much stimulation the acupuncturist would use. And like giving some patients a sugar pill in a drug trial, researchers designed “sham acupuncture” as a control group – either not inserting the needle (but rather touching the skin), or needling superficially, or needing non-acupuncture points. While a few very successful studies did show a difference between real and sham acupuncture, the vast majority of these studies had similar results, for everything from back pain to arthritis to headaches: BOTH real and sham acupuncture groups improved significantly more than a usual-care group, but real acupuncture did not perform significantly better than the sham acupuncture. This led – and still leads – scientists to conclude that acupuncture is “only a placebo” treatment, and that it isn’t actually an effective treatment.

Now, there are numerous problems with this design, and with the conclusions that are drawn from it. Traditional Chinese medicine is a complete medical system that has been used successfully for thousands of years. It has a very different way of looking at the body, different terminology, a different way of explaining why things happen. It is holistic.

Think of it like a circle. Biomedicine, on the other hand…think of it like a square. The randomized controlled trial, we often forget, is PART OF THE BIOMEDICAL SYSTEM. It was created based on a biomedical view of the body, and it is utilized based on biomedical principles. The whole point of a biomedical randomized controlled trial is to isolate and test the active ingredient in the intervention (ie, the drug)…but this whole notion is based on the understanding that there is a single active component to the intervention that is responsible for the healing. Which is not how Chinese medicine views the body, or the world, at all. Trying to prove that acupuncture is effective using a randomized controlled trial is like trying to fit a circular peg into a square hole…and then when it doesn’t fit, concluding that the circle is ineffective and wrong.

Problems with Sham Acupuncture
Sham acupuncture, as I said, is meant to mimic a placebo pill in a drug trial. This means that it is supposed to be ineffective. However, we do not yet know…from a biomedical standpoint…why acupuncture works. (We do know why acupuncture works. However, our understanding of acupuncture is based on acupuncture theory. We speak of yin and yang, qi and blood (see our earlier blog post on TCM theory). We don’t yet know, definitively, why acupuncture works from a biomedical perspective.) There are many promising theories that have proved viable in small pilot studies, such as that acupuncture may regulate the endocrine system, activate the peripheral nervous system, act directly on the brain and central nervous system, correspond to changes in the fascia of the musculoskeletal system, influence electromagnetic pathways, activate neurotransmitters, and more. However, we do not know why acupuncture works in the way that we know why a certain test drug is supposed to work. And if we don’t know what the active component of the acupuncture treatment is, how are we supposed to know how to design an inactive sham acupuncture intervention?

Some sham interventions, as I mentioned, do not actually insert the needle, but rather just touch the point of the needle to the skin. However, there are non-insertive styles of acupuncture, such as the Japanese practice of Shakuju therapy, the use of magnets, or acupressure. These are understood clinically to be active interventions. Yet they are used as a control in some acupuncture studies. Other sham interventions needle the body, but only superficially, whereas the true acupuncture group receives much deeper needling. Yet again, there are schools of acupuncture that only use superficial insertions. Most styles of Japanese acupuncture fall into this category. Still other sham interventions use acupuncture needles inserted on acupuncture points off of the understood meridians.

From the perspective of an acupuncturist, this one is harder to understand. However, it is true that acupuncture points are located in slightly different locations based on the school of acupuncture. There are hundreds of “extra” and empirical points that are not located on the main meridians.

Perhaps most importantly, the whole concept of a sham intervention relies on the belief that what makes acupuncture “acupuncture” is the actual insertion of the needles into the body. However, I think that any acupuncturist will tell you that inserting needles into the body is only one part of the treatment.

Acupuncture is based on energy. We call it “qi” in Chinese medicine. Acupuncture is an energetic treatment, and as such, we are dealing with energy. When I insert a needle into a patient, I stimulate the needle until I feel the patient’s energy wrap around the needle inside. However, this is not accounted for in a clinical trial. We don’t know how to measure qi, we don’t know what it translates to in Western medicine, and so we don’t know how to design a study that takes it into account.

Problems with Acupuncture Interventions in clinical trials
While this is slowly changing as our research community becomes more enlightened to the issues surrounding acupuncture research, the vast majority of research studies in the past have required that the acupuncturist perform a set protocol of points on their patients. However, this is never how an acupuncturist would practice in the real world. Every patient that comes in with a headache is not treated the same way. Your headache could be due to a deficiency of a certain energy, or too much of a different kind of energy, or the energy could be stuck. Your treatment would be very different based on the Chinese medical reason for the headache. Additionally, your treatment would be different based on your age, your condition, other presenting health factors, your diet, the time of year, the time of your cycle if you are female. So using a standardized protocol vastly limits what the acupuncturist can do. In reality, research studies designed this way are not testing acupuncture, as they claim, but rather they are testing that one specific protocol, which was most likely invented for the purpose of the study.

Looking forward
Luckily, researchers are starting to pay attention to all of these important points. Even funding agencies, such as the National Institute of Health and the Department of Defense, are starting to understand that perhaps a new model of testing acupuncture needs to be given a chance. Acupuncture research, most importantly, must allow the acupuncture to maintain its integrity as a powerful, holistic, individualized intervention, because otherwise what is being tested is not acupuncture. And many of these effectiveness studies that do allow acupuncture to be performed in a less fabricated way show amazing results.

So be a discerning reader when you come across a medical study on acupuncture, and remember that a circle should be measured as a circle…not as something that it is not.

5 Comments to The current problem with acupuncture research.:

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Kyu Hyun Park on Wednesday, February 23, 2011 4:06 AM
good information
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Kyu Hyun Park on Sunday, June 05, 2011 10:15 AM
I also agree that there are controversies concerning acupuncture. We need to establish the well interpreted principles and theories, on which diagnostic and therapeutic methods can be standardized. I think Korean Hand Acupuncture can be candidator in the present and near future.It documents the role and theories of acupuncture and demonstrated standard diagnostic and therapeutic methods. You can see www.soojichim.com without limitation. We need evidence based acupuncture which requires open-mind and close relationship among the scientists and medical acupuncturists who can use advanced modernized technologies.

Kyu Hyun Park on Tuesday, November 22, 2011 8:38 PM
Actually acupuncture works. Acupuncture work is different from proving the mechanism by scientists who have no concepts of acupuncture. Why do we require same measure to evaluate different phenomena? Dpn't make great mistake in approaching acupuncture.
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Michael Heyman on Wednesday, January 18, 2012 11:54 AM
Excellent article which gives an accurate picture of the methodological issues. However, there are plenty of people in the Western research community who agree that other kinds of trials apart from the fetishised double-blind are valid, such as pragmatic trials. It's not really the academic research community who says only double-blind trials are acceptable. It's the media pundits working as propaganda activists for the medical industry like Dawkins and Goldacre. Unfortunately they're very good at getting their bad science into the public mindset. Result - disaster.
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Marcie Griffith, Lic.Ac. on Wednesday, January 18, 2012 12:15 PM
Thanks for your comment! I agree that there are lots of researchers in the Western medical community who are thinking outside of the double-blind RCT box - including cohort studies, comparative effectiveness studies, and creative methodological designs. It is an exciting time to be in the research field, for sure, as more and more smart academic researchers recognize these issues and propose creative solutions. A great opportunity for integrative medicine to contribute to (and change?) the larger research paradigm!

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